LEVITRA (vardenafil HCI) - Instruction On Application
LEVITRA - international no patent the name: vardenafil HCI.
The medicinal form: the tablets covered with a cover.
Structure: Levitra 5 mg, 10 mg and 20 mg.
Each tablet contains 5 mg, 10 mg or 20 mg of Vardenafila
(5.926 mg, 11.852 mg or 23.705 mg of Vardenafila of a hydrochloride trihydrate, accordingly).
registred nomber: P No. 015037/01-2003
Pharmacological properties
Pharmacodynamics
The erection of a sexual member represents hemodynamic process in which basis the relaxation of unstriated muscles of cavernous bodies and the arterioles located in it lies.
During sex stimulation from the nervous terminations of cavernous bodies activating enzyme cGMP is allocated oxide nitrogen (N0), that leads to maintenance rising.
In cavernous bodies cyclic guanosine monophosphate. As a result there is a relaxation of unstriated muscles of cavernous bodies that promotes augmentation of inflow of a blood in a sexual member.
Blocking specific a phosphodiesterase the fifth type (PDE5), participating in splitting of a cGMP, Levitra thereby promotes intensifying of local action endogenous oxide nitrogen (N0) in cavernous bodies during sex stimulation. This effect causes ability of Levitra to strengthen reaction to sex stimulation.
Pharmacokinetics
After intake of Levitra it is quickly soaked up and starts to operate in 15 minutes (at the majority of men in 25 minutes), duration of action makes 4—5 hours.
Indications to application
Erectile dysfunction (disability to reach and keep an erection necessary for fulfilment of sexual intercourse).
Contraindications
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Hypersensitivity to any component of a preparation.
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Simultaneous application with Sodium nitritums or preparations which are donators oxide nitrogen.
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Combination with inhibitors of proteases of a HIV, such as indinavir or ritonavir.
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Levitra it is not shown women and children till 16 years.
With care it is necessary to apply at patients:
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With congenital elongation of an interval FROM;
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With anatomic deformation of a sexual member (a curvature, a cavernous fibrosis, illness of Pejroni);
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With the diseases contributing to a priapism (a sickemia, a plural myeloma, a leukaemia);
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With serious disturbance of function of a liver. With insignificant disturbance of function of a liver of change of a regimen of dosage it is not required from patients. At patients with moderate disturbance of function of a liver the initial dose makes 5 mg a day. Further depending on efficiency and shipping of treatment the dose can be enlarged as much as possible to 10 mg;
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With disease of kidneys in an end-stage. With an insignificant, moderate and serious depression of function of kidneys of change of a regimen of dosage it is not required from patients;
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With an arterial hypotension (systolic pressure in rest below 90 mm hg);
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With recently transferred stroke and a myocardial infarction; with an astable stenocardia;
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With hereditary degenerate diseases of a retina (for example, a pigmental retinitis);
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With predilection to bleedings and with a peptic ulcer exacerbation;
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With an aortal stenosis and an idiopathic hypertrophic subaortal stenosis.
Way of application and dose
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The initial dose makes 10 mg.
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Is accepted to 25—60 minutes prior to sex contact. Duration of action of Levitra makes 4—5 hours.
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The maximum recommended frequency of reception of a preparation — 1 time a day. Depending on efficiency and shipping of treatment the dose
can be enlarged to 20 mg or is lowered to 5 mg a day. -
The maximum recommended dose makes 20 mg of 1 times a day.
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The dose of 5 mg is recommended to elderly patients (is more senior 65 years).
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The dose 20 mg is prescribed in cases serious (ED) (a diabetes, a prostatectomy) when the starting dose of 10 mg appears insufficiently effective.
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Food intake and alcohol does not influence efficiency of Levitra.
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Levitra operates only at sufficient level of sex stimulation.
Side effect
Levitra as a whole it is transferred well, by-effects, as a rule, slightly or are moderately expressed and have transient character.
The most typical (1—10 %): the Headache, a face reddening, a dyspepsia, a nausea, giddiness, a rhinitis.
Atypical and rare (0,1—1 %): face edemas, a photosensitization, back pains, an arterial hypertonia, change of functional "hepatic" tests, rising of level cGMP, rising of level of a creatine kinase, myalgia, drowsiness, dyspnea, sight disturbance, running eyes, a priapism, anaphylactic reactions (including a larynx edema), an angina pectoris, an arterial hypotension, a myocardium ischemia, postural a hypotension, syncopal conditions, muscle tone rising, a nasal bleeding, a glaucoma.
Overdosage
It is known about cases of reception of Levitra in a dose of 80 mg a day which were not accompanied by development of serious collateral reactions. However, at the same time at application in a dose of 40 mg two times are a day observed the expressed back pains without signs of toxic action on muscular and nervous systems.
Interaction with other medical products
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The dose of Levitra should not exceed 5 mg at its combination to erythromycin, of ketoconazole, ltraconazole. The dose of ketoconazole and ltraconazole thus should not exceed 200 mg. The combination with indinavir and of ritonavir is contraindicative.
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Sodium nitritums, donators oxide nitrogen: the Combined appointment of Levitra and Sodium nitritums is contraindicative because of danger of development of an arterial hypotension.
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Sochetannaja therapy by alpha adrenoblockers and Levitra can be accompanied by development of an arterial hypotension. Levitra it is necessary to apply not earlier than in 6 hours after reception of alpha adrenoblockers, and its dose should not exceed 5 mg. However, at a combination to an alpha-blocker of tamsulosin, reception of preparations on time can coincide.
